CU24515B1 - PHARMACEUTICAL DOSAGE FORMS INCLUDING 1- [6- (MORFOLIN-4-IL) PYRIMIDIN-4-IL] -4- (1H-1,2,3-TRIAZOL-1-IL) -1H-PIRAZOL-5-OLATE OF SODIUM - Google Patents

PHARMACEUTICAL DOSAGE FORMS INCLUDING 1- [6- (MORFOLIN-4-IL) PYRIMIDIN-4-IL] -4- (1H-1,2,3-TRIAZOL-1-IL) -1H-PIRAZOL-5-OLATE OF SODIUM

Info

Publication number
CU24515B1
CU24515B1 CU2016000048A CU20160048A CU24515B1 CU 24515 B1 CU24515 B1 CU 24515B1 CU 2016000048 A CU2016000048 A CU 2016000048A CU 20160048 A CU20160048 A CU 20160048A CU 24515 B1 CU24515 B1 CU 24515B1
Authority
CU
Cuba
Prior art keywords
sodium
pyrimidin
olate
dosage forms
pharmaceutical dosage
Prior art date
Application number
CU2016000048A
Other languages
Spanish (es)
Other versions
CU20160048A7 (en
Inventor
Klaus Benke
Michael Formell
Heike Neumann
Gabriele Winter
Original Assignee
Bayer Pharma AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49356354&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CU24515(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Pharma AG filed Critical Bayer Pharma AG
Publication of CU20160048A7 publication Critical patent/CU20160048A7/en
Publication of CU24515B1 publication Critical patent/CU24515B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • A61K31/53771,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/04Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Diabetes (AREA)
  • Hospice & Palliative Care (AREA)
  • Hematology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

<p>La presente invención se relaciona con formas sólidas de dosificación farmacéutica para administración oral que comprenden 1-[6-(morfolin-4-il) pirimidin-4-il]-4-(1H-1,2,3-triazol-1-il)-1H-pirazol-5-olato de sodio (ingrediente activo (I), de la fórmula:</p> <p>ESPACIO PARA FÓRMULA I</p> <p>caracterizadas porque el ingrediente activo (I) contiene del 10 al 40 % de la masa total de la formulación, y como excipientes: hidroxipropilmetilcelulosa (HPMC), celulosa microcristalina o manitol, croscarmelosa de sodio, estearil fumarato de sodio o glicerildiestearato.</p> <p>Estas formas sólidas son útiles como medicamentos en la profilaxis secundaria o el tratamiento de trastornos, particularmente trastornos cardiovasculares, fallo cardíaco, anemia, trastornos renales crónicos e insuficiencia renal. </p> <p> </p><p> The present invention relates to solid pharmaceutical dosage forms for oral administration comprising 1- [6- (morpholin-4-yl) pyrimidin-4-yl] -4- (1H-1,2,3-triazole -1-yl) -1H-pyrazol-5-olate sodium (active ingredient (I), of the formula: </p> <p> SPACE FOR FORMULA I </p> <p> characterized in that the active ingredient ( I) contains from 10 to 40% of the total mass of the formulation, and as excipients: hydroxypropylmethylcellulose (HPMC), microcrystalline cellulose or mannitol, croscarmellose sodium, sodium stearyl fumarate or glyceryl distearate. </p> <p> These forms Solid are useful as drugs in secondary prophylaxis or treatment of disorders, particularly cardiovascular disorders, heart failure, anemia, chronic kidney disorders, and kidney failure. </p> <p> </p>

CU2016000048A 2013-10-17 2014-10-13 PHARMACEUTICAL DOSAGE FORMS INCLUDING 1- [6- (MORFOLIN-4-IL) PYRIMIDIN-4-IL] -4- (1H-1,2,3-TRIAZOL-1-IL) -1H-PIRAZOL-5-OLATE OF SODIUM CU24515B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13189145 2013-10-17
PCT/EP2014/071855 WO2015055564A1 (en) 2013-10-17 2014-10-13 Pharmaceutical dosage forms containing sodium-1-[6-(morpholin-4-yl)pyrimidin-4-yl]-4-(1h-1,2,3-triazol-1-yl)-1h-pyrazol-5-olate

Publications (2)

Publication Number Publication Date
CU20160048A7 CU20160048A7 (en) 2016-10-28
CU24515B1 true CU24515B1 (en) 2021-05-12

Family

ID=49356354

Family Applications (1)

Application Number Title Priority Date Filing Date
CU2016000048A CU24515B1 (en) 2013-10-17 2014-10-13 PHARMACEUTICAL DOSAGE FORMS INCLUDING 1- [6- (MORFOLIN-4-IL) PYRIMIDIN-4-IL] -4- (1H-1,2,3-TRIAZOL-1-IL) -1H-PIRAZOL-5-OLATE OF SODIUM

Country Status (35)

Country Link
US (1) US9827198B2 (en)
EP (1) EP3057580B1 (en)
JP (1) JP6525979B2 (en)
KR (1) KR102330953B1 (en)
CN (1) CN105636580B (en)
AP (1) AP2016009135A0 (en)
AR (1) AR098064A1 (en)
AU (1) AU2014336389B2 (en)
BR (1) BR112016007588A2 (en)
CA (1) CA2927437C (en)
CL (1) CL2016000857A1 (en)
CU (1) CU24515B1 (en)
DK (1) DK3057580T3 (en)
DO (1) DOP2016000078A (en)
EA (1) EA032932B1 (en)
ES (1) ES2868228T3 (en)
GT (1) GT201600072A (en)
HR (1) HRP20210691T1 (en)
HU (1) HUE054107T2 (en)
IL (1) IL244933B (en)
JO (1) JO3645B1 (en)
LT (1) LT3057580T (en)
MA (1) MA38974B2 (en)
MX (1) MX2016004628A (en)
MY (1) MY190202A (en)
NI (1) NI201600054A (en)
PE (1) PE20160669A1 (en)
PH (1) PH12016500716B1 (en)
SA (1) SA516370940B1 (en)
SI (1) SI3057580T1 (en)
TN (1) TN2016000135A1 (en)
TW (1) TWI746418B (en)
UA (1) UA119855C2 (en)
UY (1) UY35784A (en)
WO (1) WO2015055564A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3108993C (en) * 2018-08-31 2023-10-17 Astellas Pharma Inc. Pharmaceutical composition for oral administration

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102006050516A1 (en) 2006-10-26 2008-04-30 Bayer Healthcare Ag New pyrazol-3-one compounds are hypoxia-inducible transcription factor-prolyl-4-hydroxylase inhibitors useful e.g. to treat and/or prophylaxis heart-circulation diseases, heart failure, anemia, chronic kidney diseases and renal failure
EP2133096A4 (en) * 2007-03-13 2011-11-16 Dainippon Sumitomo Pharma Co Oral disintegrating tablet
DE102010044131A1 (en) * 2010-11-18 2012-05-24 Bayer Schering Pharma Aktiengesellschaft Substituted sodium 1H-pyrazole-5-olate

Also Published As

Publication number Publication date
MA38974B2 (en) 2020-11-30
BR112016007588A2 (en) 2017-09-12
HUE054107T2 (en) 2021-08-30
CN105636580B (en) 2020-03-31
TWI746418B (en) 2021-11-21
NI201600054A (en) 2016-09-21
AU2014336389B2 (en) 2020-01-30
KR102330953B1 (en) 2021-11-26
EA201690788A1 (en) 2016-09-30
WO2015055564A1 (en) 2015-04-23
HRP20210691T1 (en) 2021-06-11
SI3057580T1 (en) 2021-07-30
CL2016000857A1 (en) 2016-11-25
DK3057580T3 (en) 2021-05-10
JP2016538256A (en) 2016-12-08
SA516370940B1 (en) 2019-11-20
UA119855C2 (en) 2019-08-27
JO3645B1 (en) 2020-08-27
TW201607568A (en) 2016-03-01
UY35784A (en) 2015-05-29
TN2016000135A1 (en) 2017-10-06
EP3057580B1 (en) 2021-02-24
PE20160669A1 (en) 2016-08-04
JP6525979B2 (en) 2019-06-05
KR20160068784A (en) 2016-06-15
PH12016500716A1 (en) 2016-06-20
GT201600072A (en) 2018-12-19
NZ718063A (en) 2021-06-25
MX2016004628A (en) 2016-08-01
PH12016500716B1 (en) 2016-06-20
US20160256394A1 (en) 2016-09-08
US9827198B2 (en) 2017-11-28
EA032932B1 (en) 2019-08-30
AP2016009135A0 (en) 2016-04-30
AR098064A1 (en) 2016-04-27
IL244933B (en) 2020-11-30
CN105636580A (en) 2016-06-01
CA2927437C (en) 2022-06-28
IL244933A0 (en) 2016-05-31
LT3057580T (en) 2021-04-12
CU20160048A7 (en) 2016-10-28
DOP2016000078A (en) 2016-08-15
AU2014336389A1 (en) 2016-05-12
EP3057580A1 (en) 2016-08-24
CA2927437A1 (en) 2015-04-23
MA38974A1 (en) 2017-05-31
ES2868228T3 (en) 2021-10-21
MY190202A (en) 2022-04-04

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